Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL

NCT06333509 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CT071-HM-01
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.

Conditions

Multiple Myeloma; Primary Plasma Cell Leukemia

Keywords

CAR-T; Multiple Myeloma; Primary plasma cell myeloma; CT071; GPRC5D; anti-GPRC5D; genetically modified T-cells; hematologic cancer

Outcome Measures

Primary Outcomes (2)

• Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD).

  Frequency, type, and severity of AEs (SAEs, AESIs, laboratory abnormalities).

  Day 1 - Month 24

• Phase 2: Objective response rate

  Objective response rate (ORR) per IMWG by IRC read; percentage of participants achieving confirmed PR or better per IMWG 2016 consensus criteria.

  Day 1 - Month 24

Secondary Outcomes (9)

• Phase 1 and 2: Evaluate additional clinical efficacy outcomes

  Day 1 - Month 24

• Phase 1 and 2: Evaluate additional clinical efficacy outcomes

  Day 1 - Month 24

• Phase 1 and 2: Evaluate additional clinical efficacy outcomes

  Day 1 - Month 24

• Phase 1 and 2: Evaluate additional clinical efficacy outcomes

  Day 1 - Month 24

• Phase 2: Evaluate additional Safety of CT071.

  Day 1 - Month 24

Study Arms (2)

Phase 1

EXPERIMENTAL

Dose Escalation followed a dose expansion.

Biological: CT071

Phase 2

EXPERIMENTAL

Single group of patients for each indication (rrMM, RRpPCL).

Biological: CT071

Interventions

CT071 BIOLOGICAL

a single CAR-T infusion of CT071

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed consent;
• Age of ≥ 18;
• Willing and able to adhere to trial visit schedule and other protocol requirements
• Received sufficient prior lines of therapy;
• RRMM participants must have received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body, must be refractory to the last line of therapy, must have achieved a response (PR or better) to a least 1 prior treatment line;
• RRpPCL participants must have received at least one prior line of therapy.
• Participants must have documented diagnosis of RRMM or RRpPCL.
• The participants should have measurable disease.
• Estimated life expectancy \> 12 weeks;
• ECOG performance score 0-1;
• Participants should have bone marrow reserve, renal and hepatic functions;
• Sufficient venous access for apheresis collection, and no other contraindications to apheresis;
• Must be able to stop any anticancer therapy for planned apheresis collection
• Women of childbearing age must undergo a serum pregnancy test with negative results before screening, and are willing to use effective and reliable method of contraception for at least 12 months after T cell infusion;
• Men must be willing to use effective and reliable method of contraception for at least 12 months after T cell infusion.

You may not qualify if:

• Any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the participant to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• Pregnant or lactating women;
• HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
• Any uncontrolled active infection;
• AEs from previous treatment that have not recovered;
• Participants who have had anti-GPRC5D targeted agents;
• Participants who have received autologous stem cell transplantation 12 weeks before apheresis;
• Participants who have received allogenic stem cell transplantation within 6 months of apheresis;
• Participants who have graft versus host disease (GvHD);
• Participants who have received steroids within 14 days of apheresis or lymphodepletion;
• Participants who have plasma cell leukemia secondary to multiple myeloma, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage;
• Participants who have been administered live attenuated vaccine 4 weeks before apheresis or lymphodepletion;
• Participants who are allergic to fludarabine, cyclophosphamide, tocilizumab, dimethyl sulfoxide (DMSO) or CT071;
• Participants who have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
• Participants who require supplemental oxygen;

Sponsors & Collaborators

• CARsgen Therapeutics Co., Ltd.: lead

MeSH Terms

Conditions

Multiple Myeloma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Central Study Contacts

CARsgen US

CONTACT

CentralNumber; clinicalUS@carsgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: N/Ap
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1; Dose escalation followed by dose expansion Phase 2; Single group of each indication will be dosed at the recommended dose level from Phase 1.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 27, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2024

Record last verified: 2024-03